CQV Engineer

Vedi l’offerta su Go Lavoro: golavoro.it/annuncio-lavoro/7d0qqn

Position Description
We are now seeking a CQV Engineer to join our growing operations in Italy. The CQV Engineer develops the documentation to support Commissioning, Qualifications, and Validation, including protocol writing and execution, field verification, and the development of summary reports at the client site.
Key Responsibilities
- Support documentation for the Commissioning, Qualification, and Validation of pharmaceutical facilities, utilities, and equipment.
- Write and execute protocols, perform field verification, and develop summary reports at client sites.
- Provide cGMP leadership and guidance for the integration and delivery of CQV services for Life Sciences clients.
- Apply excellent technical problem‑solving and troubleshooting skills, addressing typical project technical issues and deadlines.
- Work independently while quickly building and nurturing a project team.
- Manage the C&Q; documentation and execution lifecycle from SLIA generation through OQ completion.
- Support onsite and offsite activities such as FATs, SATs, IOQ and PQ executions, and system walkdowns.




- Be proficient in life science manufacturing processes (biotech, aseptic processing, aseptic fill/finish, OSD, Gene Therapy or equivalent).
- Familiarity with Baseline Guide 5 (Second Edition) is a plus.
- Have experience with isolator qualification protocols, VHP cycle development, and GMP‑based knowledge.
- Demonstrate expertise in Microsoft Word and Excel.
- Excellent oral and written English are required.
- Available for travel in Italy and abroad.

Position Requirements
- High attention to detail.
- Ability to multi‑task and take initiative to accomplish assigned tasks accurately.
- BS or MS in a relevant science or engineering field, or equivalent years of hands‑on experience.
- Minimum 2–3 years’ experience performing commissioning and/or qualification activities in an FDA‑regulated industry, especially in facilities and equipment startup, walk‑downs & troubleshooting, utilities

Vedi l’offerta su Go Lavoro: golavoro.it/annuncio-lavoro/7d0qqn